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| Background on Applicable Federal Regulations |
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| DSHEA (Dietary Supplement Health and Education Act): Passed in 1994, DSHEA codified lax regulation on dietary supplements at a time when the industry was comprised of approximately 500 dietary supplement manufacturers in the U.S., selling approximately 4,000 products (largely vitamins and established mineral supplements). This law also broadened the definition of dietary supplement beyond just vitamins, minerals and amino acids to include proteins, herbals, botanicals and their extracts, and includes products that are not food or drugs but are intended to supplement the diet. |
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| The limitation of DSHEA, as expressed by the FDA, is that "unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for FDA to 'approve' dietary supplements... before they reach the consumer." The problem is compounded by the shift of burden, which requires the FDA to prove that the product is "unsafe" before it can take any action to remove a product from the marketplace and only requires reporting of "serious" adverse effects. |
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| Anabolic Steroid Control Act of 1990: Added steroids to Schedule III of the Controlled Substances Act (CSA). The definition of steroid did not include steroid precursors or prohormones that, once ingested, are converted by the body into steroids. |
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| Anabolic Steroid Control Act of 2004: Amended the CSA and replaced the existing definition of "anabolic steroid" with a definition that eliminated the burden on the Government to prove that a substance promoted muscle growth before it could be classified as a steroid. The 2004 Act also listed 59 specific substances (e.g. androstenedione, THG and other substances) as being anabolic steroids. Despite some progress, a lengthy administrative process is still necessary to add additional steroids and precursors to the CSA. |
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| In one specific example, it has taken nearly four years to work through the administrative process in order to add three steroids to the CSA. The process was initiated in January 2006 by the Drug Enforcement Agency to schedule three steroids (boldione; desoxymethyltestosterone; and 19-nor-4,9(10)-androstadienedione). As of October 2009, the process had not yet been completed. So, while the 2004 Act made it possible to add additional steroids to the CSA, the process has proven too cumbersome and slow to effectively manage the ever exploding number of precursors and steroids sold under the protection of DSHEA. |
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| We invite you to join our efforts and take action now. |
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